Why it was recalled
CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
Product description
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-524-02, and b) 55 gallon bottle (208,198 ml), NDC 55533-524-03, Manufactured for: Multi-Mist Products A Division of NCH Corporation 1618 Northgate, Irving, Texas 75062
Lot numbers, UPCs & expiration codes
Lots: 12032504, 12014282, 12013501, 12104039, 12013505, 12032523, 12013510, 12014804, 12015401, and 12014113
Where it was sold
Nationwide in United States and Canada.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0092-2023
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Dec 9, 2022
- FDA report date
- Jan 4, 2023
- Quantity
- 10,930 gallons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- NCH Life Sciences LLC
Original FDA data
Every field from FDA enforcement report D-0092-2023, exactly as published.
Show all FDA fields
- City
- Irving
- State
- TX
- Status
- Completed
- Country
- United States
- Event ID
- 91272
- Address
- 2730 Carl Rd
- Code information
- Lots: 12032504, 12014282, 12013501, 12104039, 12013505, 12032523, 12013510, 12014804, 12015401, and 12014113
- Postal code
- 75062-6405
- Report date
- Jan 4, 2023
- Product type
- Drugs
- Recall number
- D-0092-2023
- Classification
- Class II
- Recalling firm
- NCH Life Sciences LLC
- Product quantity
- 10,930 gallons
- Reason for recall
- CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-524-02, and b) 55 gallon bottle (208,198 ml), NDC 55533-524-03, Manufactured for: Multi-Mist Products A Division of NCH Corporation 1618 Northgate, Irving, Texas 75062
- Distribution pattern
- Nationwide in United States and Canada.
- Recall initiation date
- Dec 9, 2022
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Dec 28, 2022